Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-10 @ 11:38 PM
Study NCT ID:
NCT01742234
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2012-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RELIVE Informed Consent Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009927', 'term': 'Tissue and Organ Procurement'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire Score 1', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."'}, {'measure': 'Questionnaire Score 2', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."'}, {'measure': 'Questionnaire Score 3', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."'}], 'secondaryOutcomes': [{'measure': 'Questionnaire Score Secondary Endpoint 1', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding of short-term medical risks of donation answered on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."'}, {'measure': 'Questionnaire Score Secondary Endpoint 2', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding of long-term medical risks of donation expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."'}, {'measure': 'Questionnaire Score Secondary Endpoint 3', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding of psychological risks of donation expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."'}, {'measure': 'Questionnaire Score Secondary Endpoint 4', 'timeFrame': 'Change from 1 week prior to donation and 3 months after donation', 'description': 'Understanding that recipients may have variable outcomes as expressed by donors on a scale of 1 to 4 e.g.; "1: No understanding" to "4: Full understanding."'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Living Donors', 'Tissue Donors']}, 'referencesModule': {'availIpds': [{'id': 'SDY292', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY292', 'type': 'Individual Participant Data Set', 'comment': 'ImmPort study identifier is SDY292'}, {'id': 'SDY292', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY292', 'type': 'Study Protocol', 'comment': 'ImmPort study identifier is SDY292. The study protocol is available in the Design tab section.'}], 'references': [{'pmid': '21158924', 'type': 'RESULT', 'citation': 'Valapour M, Kahn JP, Bailey RF, Matas AJ. Assessing elements of informed consent among living donors. Clin Transplant. 2011 Mar-Apr;25(2):185-90. doi: 10.1111/j.1399-0012.2010.01374.x. Epub 2010 Dec 16.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID) website'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT) website'}]}, 'descriptionModule': {'briefSummary': "An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People who will be donating at kidney at the University of Minnesota, Mayo Clinic, or University of Alabama or people who will be donating a lung at University of Washington Medical School or the University of Southern California', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living donor of a kidney or lung\n\nExclusion Criteria:\n\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01742234', 'briefTitle': 'RELIVE Informed Consent Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study', 'orgStudyIdInfo': {'id': 'DAIT RELIVE 03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney Donors', 'description': 'People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama', 'interventionNames': ['Procedure: Organ Donation']}, {'label': 'Lung Donors', 'description': 'People who will donate a lung at the Washington University School of Medicine or the University of Southern California', 'interventionNames': ['Procedure: Organ Donation']}], 'interventions': [{'name': 'Organ Donation', 'type': 'PROCEDURE', 'description': 'People in this study will donate either a lung or kidney', 'armGroupLabels': ['Kidney Donors', 'Lung Donors']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maryam Valapour, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota, Center for Bioethics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}